NADOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V)

Available from:

American Health Packaging

INN (International Name):

NADOLOL

Composition:

NADOLOL 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris. Nadolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's

Product summary:

Nadolol Tablets, USP are supplied as : 20 mg tablets : Yellow, round, biconvex tablets debossed "347" on one side and 'I' on the left side of the bisect and 'G' on the right side of bisect on other. Unit dose packages of 30 (5 x 6) NDC 60687-302-25 40 mg tablets: Yellow, round, biconvex tablets debossed "348" on one side and 'I' on the left side of the bisect and 'G' on the right side of bisect on other. Unit dose packages of 30 (5 x 6) NDC 60687-313-25 STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NADOLOL- NADOLOL TABLET
AMERICAN HEALTH PACKAGING
----------
NADOLOL TABLETS, USP
8430225/0317OS
RX ONLY
DESCRIPTION
Nadolol is a synthetic nonselective beta-adrenergic receptor blocking
agent designated
chemically as 1-( _tert_-butylamino)-3-[(5,6,7,8-tetrahydro-
_cis_-6,7-dihydroxy-1-
naphthyl)oxy]-2-propanol. Structural formula:
Nadolol, USP is a white crystalline powder. It is freely soluble in
ethanol, soluble in
hydrochloric acid, slightly soluble in water and in chloroform, and
very slightly soluble in
sodium hydroxide.
Nadolol tablets, USP are available for oral administration as 20 mg,
40 mg, and 80 mg
tablets. Inactive ingredients: lactose monohydrate, microcrystalline
cellulose, povidone,
D&C yellow No. 10, croscarmellose sodium, and magnesium stearate.
CLINICAL PHARMACOLOGY
Nadolol is a nonselective beta-adrenergic receptor blocking agent.
Clinical pharmacology
studies have demonstrated beta-blocking activity by showing (1)
reduction in heart rate
and cardiac output at rest and on exercise, (2) reduction of systolic
and diastolic blood
pressure at rest and on exercise, (3) inhibition of
isoproterenol-induced tachycardia, and
(4) reduction of reflex orthostatic tachycardia.
Nadolol specifically competes with beta-adrenergic receptor agonists
for available beta
receptor sites; it inhibits both the beta
receptors located chiefly in cardiac muscle and
the beta
receptors located chiefly in the bronchial and vascular musculature,
inhibiting
the chronotropic, inotropic, and vasodilator responses to
beta-adrenergic stimulation
proportionately. Nadolol has no intrinsic sympathomimetic activity
and, unlike some
other beta-adrenergic blocking agents, nadolol has little direct
myocardial depressant
activity and does not have an anesthetic-like membrane-stabilizing
action. Animal and
human studies show that nadolol slows the sinus rate and depresses AV
conduction. In
dogs, only minimal amounts of nadolol were detected in the brain
relative to amounts in
1
2
blood and other organs and tissues. Nadolol has low lipop